Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean (NARELESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872248
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : July 27, 2011
Information provided by:
Nanjing Medical University

Brief Summary:
The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting approximately 10% of the population. Different literature had different views on the association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some reported that spinal anesthesia induced postoperative restless leg syndrome, but other studies showed that spinal and general anesthesia all two did not cause restless leg syndrome. A potential difference amongst these studies is that a big difference exists in surgical types. The investigators proposed that different types of surgery performed undergoing various anesthesia, and that there is a big difference in original pathophysiological condition. Therefore, the investigators hypothesized that pregnant women who have special physical states would have had an association between neuraxial anesthesia and restless leg syndrome in such patients who received selective cesarean section undergoing spinal or epidural anesthesia.

Condition or disease Intervention/treatment Phase
Cesarean Section Restless Leg Syndrome Procedure: Spinal anesthesia Procedure: Epidural anesthesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery
Study Start Date : February 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Parturients received spinal anesthesia
Procedure: Spinal anesthesia
Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
Other Name: Intrathecal anesthesia
Active Comparator: 2
Parturients received epidural anesthesia
Procedure: Epidural anesthesia
Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
Other Name: Extradural anesthesia

Primary Outcome Measures :
  1. Occurrence of restless leg syndrome [ Time Frame: One day to one week after completion of cesarean ]

Secondary Outcome Measures :
  1. Intraoperative anesthetic effectiveness [ Time Frame: From the beginning of anesthesia (0 min) to completion of cesarean (45 min) ]
    The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means

  2. Postoperative analgesic effectiveness [ Time Frame: From the initiation of analgesia (0 min) to 48 h after cesarean ]
    This will be assessed with visual analog scale (VAS) of pain in a 0 to 10cm scoring bar

  3. Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity [ Time Frame: From the completion of cesarean (1 day) to one week follow-up ]
  4. Psychological state [ Time Frame: From one day to one week follow-up after cesarean ]
    This will be assessed with self anxiety and depression scales

  5. Infant weight [ Time Frame: Three min after cesarean section ]
  6. One-min Apgar score [ Time Frame: One min after cesarean section ]
  7. Five-min Apgar score [ Time Frame: Five min after cesarean section ]
  8. Intraoperative vital signs [ Time Frame: From the beginning of cesarean (0 min) to completion of operation (45 min) ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy pregnancy
  • Selective cesarean
  • Gestational age >= 37 weeks
  • Chinese

Exclusion Criteria:

  • Allergic to local anesthetics
  • Allergic to opioids
  • History of psychosis
  • Cognition malfunction
  • Any organic diseases
  • Original lower extremity dyskinesia and paraesthesia
  • Chronic pain
  • Difficult in sleep
  • Drug and alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872248

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Study Director: XiaoFeng Shen, MD Nanjing Medical University

Responsible Party: XiaoFeng Shen, Nanjing Medical University Identifier: NCT00872248     History of Changes
Other Study ID Numbers: NMU-200903-MZ005
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: May 2011

Keywords provided by Nanjing Medical University:
Restless leg syndrome
Spinal anesthesia
Epidural anesthesia
Neuraxial block

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Central Nervous System Depressants
Physiological Effects of Drugs